SOP for Cleaning of Rapid Mixer Granulator (R.M.G.)

1.0 OBJECTIVE:

To lay down the cleaning procedure for Rapid Mixer Granulator (R.M.G.).

2.0 SCOPE:

This SCP shall be applicable to Rapid Mixer Granulator (R.M.G.) in Granulation area in Production department.

3.0 RESPONSIBILITY:

3.1 Execution :Operator
3.2 Checking :Pharmacist and Above

4.0 ACCOUNTABILITY:

HOD-Production

5.0 PROCEDURE:

5.1 Put “OFF” the electrical supply & cover all the electrical parts with poly bags.
5.2 Remove air vent filter bag and clean with 3 liter potable water and finally clean with 3 liter purified water.
5.3 Wipe off all residual powder from external surface of RMG with dry clean lint free cloth followed by wet cloth.
5.4 Clean the external surface of RMG with about 50 liter of potable water followed by 2.5% “Teepol” solution and again rinse with 50 liter potable water.
5.5 Start the purging air, Closed the discharge valve and fills the RMG (by using a flexible PVC hosepipe) with 150 liter of potable water or sufficient quantity of potable water so that impeller and chopper dip into potable water.
5.6 Start the impeller & chopper at slow speed for 5 minute followed by both impeller and chopper at fast speed for 2 minutes.
5.7 Stop the impeller and chopper.
5.8 Open the discharge port and run impeller at slow speed to drain the water to the designated draining system. Stop the impeller after completion of drain.
5.9 Open the lid and wipe with clean lint free cloth.
5.10 Dismantle the impeller and chopper.
5.11 Clean all the parts with Potable water then 2.5 %“Teepol” solution.
5.12 Clean all the parts at least two times with potable water till the entire residue is removed.
5.13 Assemble the impeller and chopper.

5.14 Start the purging air, Close discharge port, open lid, and collect about 100 liter hot water and repeat step 5.6 to 5.8.Start the purging air, Close discharge port, open lid, and collect about 200 liter purified water and repeat step 5.6 to 5.8.
5.15 Open the lid and wipe with clean and lint free cloth.
5.16 Wipe off all the parts with 70 % v/v solution of Isopropyl Alcohol (IPA).
5.17 Affix “Cleaned” status label on the equipment.
5.18 Fill the “Equipment Log Book”.
5.19 Re-cleaned if not used within 72 hours.

6.0 ABBREVIATIONS:

SCP :Standard Cleaning Procedure

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